External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak.
Identifieur interne : 001243 ( PubMed/Corpus ); précédent : 001242; suivant : 001244External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak.
Auteurs : Moon Woo Seong ; Seung Jun Lee ; Sung Im Cho ; Kyungphil Ko ; Mi Na Kim ; Heungsub Sung ; Jae Seok Kim ; Ji Soo Ahn ; Byung Su Yu ; Taek Soo Kim ; Eui Chong Kim ; Sung Sup ParkSource :
- Annals of laboratory medicine [ 2234-3814 ] ; 2016.
English descriptors
- KwdEn :
- Coronavirus Infections (diagnosis), Coronavirus Infections (epidemiology), Coronavirus Infections (virology), Disease Outbreaks, Humans, Middle East Respiratory Syndrome Coronavirus (genetics), Middle East Respiratory Syndrome Coronavirus (isolation & purification), Molecular Diagnostic Techniques (standards), Quality Assurance, Health Care, RNA, Viral (analysis), Real-Time Polymerase Chain Reaction, Republic of Korea (epidemiology), Surveys and Questionnaires.
- MESH :
- chemical , analysis : RNA, Viral.
- diagnosis : Coronavirus Infections.
- epidemiology : Coronavirus Infections, Republic of Korea.
- genetics : Middle East Respiratory Syndrome Coronavirus.
- isolation & purification : Middle East Respiratory Syndrome Coronavirus.
- standards : Molecular Diagnostic Techniques.
- virology : Coronavirus Infections.
- Disease Outbreaks, Humans, Quality Assurance, Health Care, Real-Time Polymerase Chain Reaction, Surveys and Questionnaires.
Abstract
The largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infection outside Middle East Asia in 2015 has necessitated the rapid expansion of laboratories that conduct MERS-CoV molecular testing in Korea, together with external quality assessment (EQA) to evaluate the assays used.
DOI: 10.3343/alm.2016.36.3.230
PubMed: 26915611
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Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Ko, Kyungphil" sort="Ko, Kyungphil" uniqKey="Ko K" first="Kyungphil" last="Ko">Kyungphil Ko</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Mi Na" sort="Kim, Mi Na" uniqKey="Kim M" first="Mi Na" last="Kim">Mi Na Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Sung, Heungsub" sort="Sung, Heungsub" uniqKey="Sung H" first="Heungsub" last="Sung">Heungsub Sung</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Jae Seok" sort="Kim, Jae Seok" uniqKey="Kim J" first="Jae Seok" last="Kim">Jae Seok Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Ahn, Ji Soo" sort="Ahn, Ji Soo" uniqKey="Ahn J" first="Ji Soo" last="Ahn">Ji Soo Ahn</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Yu, Byung Su" sort="Yu, Byung Su" uniqKey="Yu B" first="Byung Su" last="Yu">Byung Su Yu</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Taek Soo" sort="Kim, Taek Soo" uniqKey="Kim T" first="Taek Soo" last="Kim">Taek Soo Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Eui Chong" sort="Kim, Eui Chong" uniqKey="Kim E" first="Eui Chong" last="Kim">Eui Chong Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Park, Sung Sup" sort="Park, Sung Sup" uniqKey="Park S" first="Sung Sup" last="Park">Sung Sup Park</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea. sparkle@snu.ac.kr.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26915611</idno><idno type="pmid">26915611</idno><idno type="doi">10.3343/alm.2016.36.3.230</idno><idno type="wicri:Area/PubMed/Corpus">001243</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001243</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak.</title><author><name sortKey="Seong, Moon Woo" sort="Seong, Moon Woo" uniqKey="Seong M" first="Moon Woo" last="Seong">Moon Woo Seong</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Lee, Seung Jun" sort="Lee, Seung Jun" uniqKey="Lee S" first="Seung Jun" last="Lee">Seung Jun Lee</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Cho, Sung Im" sort="Cho, Sung Im" uniqKey="Cho S" first="Sung Im" last="Cho">Sung Im Cho</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Ko, Kyungphil" sort="Ko, Kyungphil" uniqKey="Ko K" first="Kyungphil" last="Ko">Kyungphil Ko</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Mi Na" sort="Kim, Mi Na" uniqKey="Kim M" first="Mi Na" last="Kim">Mi Na Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Sung, Heungsub" sort="Sung, Heungsub" uniqKey="Sung H" first="Heungsub" last="Sung">Heungsub Sung</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Jae Seok" sort="Kim, Jae Seok" uniqKey="Kim J" first="Jae Seok" last="Kim">Jae Seok Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Ahn, Ji Soo" sort="Ahn, Ji Soo" uniqKey="Ahn J" first="Ji Soo" last="Ahn">Ji Soo Ahn</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Yu, Byung Su" sort="Yu, Byung Su" uniqKey="Yu B" first="Byung Su" last="Yu">Byung Su Yu</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Taek Soo" sort="Kim, Taek Soo" uniqKey="Kim T" first="Taek Soo" last="Kim">Taek Soo Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Eui Chong" sort="Kim, Eui Chong" uniqKey="Kim E" first="Eui Chong" last="Kim">Eui Chong Kim</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Park, Sung Sup" sort="Park, Sung Sup" uniqKey="Park S" first="Sung Sup" last="Park">Sung Sup Park</name><affiliation><nlm:affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea. sparkle@snu.ac.kr.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Annals of laboratory medicine</title><idno type="eISSN">2234-3814</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Coronavirus Infections (diagnosis)</term><term>Coronavirus Infections (epidemiology)</term><term>Coronavirus Infections (virology)</term><term>Disease Outbreaks</term><term>Humans</term><term>Middle East Respiratory Syndrome Coronavirus (genetics)</term><term>Middle East Respiratory Syndrome Coronavirus (isolation & purification)</term><term>Molecular Diagnostic Techniques (standards)</term><term>Quality Assurance, Health Care</term><term>RNA, Viral (analysis)</term><term>Real-Time Polymerase Chain Reaction</term><term>Republic of Korea (epidemiology)</term><term>Surveys and Questionnaires</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>RNA, Viral</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Coronavirus Infections</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Coronavirus Infections</term><term>Republic of Korea</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Molecular Diagnostic Techniques</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Coronavirus Infections</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disease Outbreaks</term><term>Humans</term><term>Quality Assurance, Health Care</term><term>Real-Time Polymerase Chain Reaction</term><term>Surveys and Questionnaires</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infection outside Middle East Asia in 2015 has necessitated the rapid expansion of laboratories that conduct MERS-CoV molecular testing in Korea, together with external quality assessment (EQA) to evaluate the assays used.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26915611</PMID><DateCompleted><Year>2017</Year><Month>01</Month><Day>09</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2234-3814</ISSN><JournalIssue CitedMedium="Internet"><Volume>36</Volume><Issue>3</Issue><PubDate><Year>2016</Year><Month>May</Month></PubDate></JournalIssue><Title>Annals of laboratory medicine</Title><ISOAbbreviation>Ann Lab Med</ISOAbbreviation></Journal><ArticleTitle>External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak.</ArticleTitle><Pagination><MedlinePgn>230-4</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3343/alm.2016.36.3.230</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infection outside Middle East Asia in 2015 has necessitated the rapid expansion of laboratories that conduct MERS-CoV molecular testing in Korea, together with external quality assessment (EQA) to evaluate the assays used.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The EQA program consisted of two phases; self-validation and blind assessment. For the first EQA phase, in vitro transcribed upstream region of the envelope gene (upE) and the open reading frame (ORF)1a RNAs were used at a concentration of 1,000 copies/μL. The test panel for the second EQA phase consisted of RNA extracts from three samples, which were obtained from two MERS-CoV positive patients and one MERS-CoV negative patient.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The first EQA phase results for 46 participants showed a linear relationship between the threshold cycle (C(T)) values of RNA materials and the logarithmic concentrations for both upE and ORF1a gene targets (R²=0.73 and 0.75, respectively). The mean C(T) value for each concentration was different depending on which commercial kit was used for the assay. Among the three commonly used kits, PowerChek MERS Real-Time PCR kit (KogeneBiotech, Korea) showed the lowest C(T) values at all concentrations of upE and most concentrations of ORF1a. The second EQA phase results for 47 participants were 100% correct for all tested samples.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This EQA survey demonstrates that the MERS-CoV molecular testing performed in Korea during the 2015 outbreak is of robust capability. However, careful establishment and validation of a cut-off value are recommended to ensure good analytical sensitivity.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Seong</LastName><ForeName>Moon Woo</ForeName><Initials>MW</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Seung Jun</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cho</LastName><ForeName>Sung Im</ForeName><Initials>SI</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ko</LastName><ForeName>Kyungphil</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Mi Na</ForeName><Initials>MN</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sung</LastName><ForeName>Heungsub</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Jae Seok</ForeName><Initials>JS</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ahn</LastName><ForeName>Ji Soo</ForeName><Initials>JS</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yu</LastName><ForeName>Byung Su</ForeName><Initials>BS</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Taek Soo</ForeName><Initials>TS</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Eui Chong</ForeName><Initials>EC</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Park</LastName><ForeName>Sung Sup</ForeName><Initials>SS</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea. sparkle@snu.ac.kr.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>Korea (South)</Country><MedlineTA>Ann Lab Med</MedlineTA><NlmUniqueID>101571172</NlmUniqueID><ISSNLinking>2234-3806</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D012367">RNA, Viral</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="Y">diagnosis</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004196" MajorTopicYN="N">Disease Outbreaks</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D065207" MajorTopicYN="N">Middle East Respiratory Syndrome Coronavirus</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="Y">genetics</QualifierName><QualifierName UI="Q000302" MajorTopicYN="N">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D025202" MajorTopicYN="N">Molecular Diagnostic Techniques</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011785" MajorTopicYN="N">Quality Assurance, Health Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012367" MajorTopicYN="N">RNA, Viral</DescriptorName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D060888" MajorTopicYN="N">Real-Time Polymerase Chain Reaction</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D056910" MajorTopicYN="N">Republic of Korea</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">External quality assessment</Keyword><Keyword MajorTopicYN="N">MERS-CoV</Keyword><Keyword MajorTopicYN="N">Molecular diagnostics</Keyword><Keyword MajorTopicYN="N">ORF1a</Keyword><Keyword MajorTopicYN="N">Real-time PCR</Keyword><Keyword MajorTopicYN="N">upE</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>09</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>11</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>01</Month><Day>29</Day></PubMedPubDate><PubMedPubDate 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